Ocular insert apparatus and methods

Abstract

A comfortable insert comprises a retention structure sized for placement under the eyelids and along at least a portion of conjunctival sac of the upper and lower lids of the eye. The retention structure resists deflection when placed in the conjunctival sac of the eye and to guide the insert along the sac when the eye moves. The retention structure can be configured in many ways to provide the resistance to deflection and may comprise a hoop strength so as to urge the retention structure outward and inhibit movement of the retention structure toward the cornea. The insert may move rotationally with deflection along the conjunctival sac, and may comprise a retention structure having a cross sectional dimension sized to fit within folds of the conjunctiva. The insert may comprise a release mechanism and therapeutic agent to release therapeutic amounts of the therapeutic agent for an extended time.

1 - 113 . (canceled) 
     
     
         114 . An ocular insert for delivering at least one therapeutic agent to an eye for an extended period of time, the insert comprising:
 a first structure configured to be positioned on the eye outside a cornea of the eye and at least partially underneath at least one of the upper and lower eyelids, wherein the first structure provides a first shape of the ocular insert;   a second structure supported by the first structure, wherein the second structure is of a different durometer than a material of the first structure; and   at least one therapeutic agent coupled to the ocular insert;   wherein the ocular insert has a first shape prior to being positioned onto the eye, and the ocular insert confirms in situ to a second shape upon being positioned onto the eye for a period of time, and wherein, upon being removed from the eye, the ocular insert has a shape that is different from the first shape.   
     
     
         115 . An ocular insert as in  claim 114 , wherein the second shape conforms to a shape of the eye. 
     
     
         116 . An ocular insert as in  claim 114 , wherein the second shape conforms at least in part to an anterior surface of the eye. 
     
     
         117 . An ocular insert as in  claim 114 , wherein the second shape conforms at least in part to an anterior surface of the eye outside of the cornea 
     
     
         118 . An ocular insert as in  claim 114 , wherein the second shape conforms at least in part to a region of a fornix of the eye. 
     
     
         119 . An ocular insert as in  claim 114 , wherein the second shape conforms at least in part to a shape of the bony orbit of the eye. 
     
     
         120 . An ocular insert as in  claim 114 , wherein the removed shape retains a different shape than the first shape. 
     
     
         121 . An ocular insert as in  claim 114 , wherein the ocular insert resists deflection away from the removed shape upon being removed from the eye. 
     
     
         122 . An ocular insert as in  claim 114 , wherein the first shape is annular. 
     
     
         123 . An ocular insert as in  claim 114 , wherein the first shape is positioned substantially within a first plane and the removed shape at least partially extends outside of the first plane. 
     
     
         124 . A method of treating an eye of a patient, the method comprising:
 placing a ring-shaped drug delivery device onto an anterior surface of the eye, the drug delivery device comprising:   an inner structure;   an outer matrix structure encapsulating a length of the inner structure; and   a therapeutic agent configured to be released from the device for an extended time,   wherein an inner diameter of the ring-shaped drug delivery device is at least as large as an outer diameter of the eye's cornea, and wherein the drug delivery device has a pre-insertion contour prior to being placed on the eye that is generally planar;   conforming in situ the pre-insertion contour of the drug delivery device to a post-insertion contour that is generally non-planar; and   releasing the therapeutic agent from the device for the extended time, wherein the drug delivery device is configured to retain the post-insertion contour for a period of time after removal from the eye.   
     
     
         125 . The method of  claim 124 , wherein placing the device onto the anterior surface comprises placing the device at least partially within conjunctival sacs. 
     
     
         126 . The method of  claim 124 , wherein placing the device onto the anterior surface comprises placing the device on a conjunctiva, wherein the device is received in one or more of a plurality of folds of the conjunctiva. 
     
     
         127 . The method of  claim 126 , wherein the one or more of the plurality of folds comprises a plurality of bulbar folds of the conjunctiva. 
     
     
         128 . The method of  claim 127 , wherein the device is movable along the bulbar conjunctiva when the eye moves to retain the device on the conjunctiva. 
     
     
         129 . The method of  claim 126 , wherein the one or more of the plurality of folds comprises a plurality of palpebral folds of the conjunctiva. 
     
     
         130 . The method of  claim 124 , further comprising:
 measuring a dimension of the patient to obtain a measured dimension; and   identifying, based on the measured dimension, the drug delivery device among a plurality of drug delivery devices having different inner diameters.   
     
     
         131 . The method of  claim 130 , wherein the measured dimension comprises one or more of a circumference of the head of the patient, a dimension between eyes of the patient, a depth of the upper fornix, a depth of the lower fornix, a distance extending between a lateral canthus and a medial canthus of the eye, a distance extending between a cul-de-sac of the eye and a limbus of the eye, a dimension of the orbit, or a fornix depth measured with a fornicometer. 
     
     
         132 . The method of  claim 124 , further comprising:
 placing a second ring-shaped drug delivery device on a second eye of the patient, the second drug delivery device comprising:
 an inner skeletal structure; 
 an outer matrix structure encapsulating a length of the inner structure; and 
 a therapeutic agent configured to be released from the device for an extended time; and 
   releasing the therapeutic agent from the second drug delivery device.   
     
     
         133 . The method of  claim 124 , wherein the extended time the therapeutic agent is released is at least about one week up to about six months.